This article is presented by EFPIA with the support of AbbVie I made a trip back to Europe recently, where I spent the vast majority of my pharmaceutical career, to share my perspectives on competitiveness at the European Health Summit. Now that I work in a role responsible for supporting patient access to medicine globally, I view Europe, and how it compares internationally, through a new lens, and I have been reflecting further on why the choices made today will have such a critical impact on where medicines are developed tomorrow. Today, many patients around the world benefit from medicines built on European science and breakthroughs of the last 20 years. Europeans, like me, can be proud of this contribution. As I look forward, my concern is that we may not be able to make the same claim in the next 20 years. It’s clear that Europe has a choice. Investing in sustainable medicines growth and other enabling policies will, I believe, bring significant benefits. Not doing so risks diminishing global influence. > Today, many patients around the world benefit from medicines built on European > science and breakthroughs of the last 20 years I reflect on three important points: 1) investment in healthcare benefits individuals, healthcare and society, but the scale of this benefit remains underappreciated; 2) connected to this, the underpinning science for future innovation is increasingly happening elsewhere; and 3) this means the choices we make today must address both of these trends. First, let’s use the example of migraine. As I have heard a patient say, “Migraine will not kill you but neither [will they] let you live.”[1] Individuals can face being under a migraine attack for more than half of every month, unable to leave home, maintain a job and engage in society.[2] It is the second biggest cause of disability globally and the first among young women.[3] It affects the quality of life of millions of Europeans.[4] From 2011-21 the economic burden of migraine in Europe due to the loss of working days ranged from €35-557 billion, depending on the country, representing 1-2 percent of gross domestic product (GDP).[5]   Overall socioeconomic burden of migraine as percentage of the country’s GDP in 2021 Source: WifOR, The socioeconomic burden of migraine. The case of 6 European Countries.5 Access to effective therapies could radically improve individuals’ lives and their ability to return to work.[6] Yet, despite the staggering economic and personal impacts, in some member states the latest medicines are either not reimbursed or only available after several treatment failures.[7] Imagine if Europe shifted its perspective on these conditions, investing to improve not only health but unlocking the potential for workforce and economic productivity? Moving to my second point, against this backdrop of underinvestment, where are scientific advances now happening in our sector? In recent years it is impressive to see China has become the second-largest drug developer in the world,[8] and within five years it may lead the innovative antibodies therapeutics sector,[9] which is particularly promising for complex areas like oncology. Cancer is projected to become the leading cause of death in Europe by 2035,[10] yet the continent’s share of the number of oncology trials dropped from 41 percent in 2013 to 21 percent in 2023.10 Today, antibody-drug conjugates are bringing new hope in hard-to-treat tumor types,[11] like ovarian,[12] lung[13] and colorectal[14] cancer, and we hope to see more of these advances in the future. Unfortunately, Europe is no longer at the forefront of the development of these innovations. This geographical shift could impact high-quality jobs, the vitality of Europe’s biotech sector and, most importantly, patients’ outcomes. [15] > This is why I encourage choices to be made that clearly signal the value > Europe attaches to medicines This is why I encourage choices to be made that clearly signal the value Europe attaches to medicines. This can be done by removing national cost-containment measures, like clawbacks, that are increasingly eroding the ability of companies to invest in European R&D. To provide a sense of their impact, between 2012 and 2023, clawbacks and price controls reduced manufacturer revenues by over €1.2 billion across five major EU markets, corresponding to a loss of 4.7 percent in countries like Spain.[16] Moreover, we should address health technology assessment approaches in Europe, or mandatory discount policies, which are simply not adequately accounting for the wider societal value of medicines, such as in the migraine example, and promoting a short-term approach to investment. By broadening horizons and choosing a long-term investment strategy for medicines and the life science sector, Europe will not only enable this strategic industry to drive global competitiveness but, more importantly, bring hope to Europeans suffering from health conditions. AbbVie SA/NV – BE-ABBV-250177 (V1.0) – December 2025 -------------------------------------------------------------------------------- [1] The Parliament Magazine, https://www.theparliamentmagazine.eu/partner/article/unmet-medical-needs-and-migraine-assessing-the-added-value-for-patients-and-society, Last accessed December 2025. [2] The Migraine Trust; https://migrainetrust.org/understand-migraine/types-of-migraine/chronic-migraine/, Last accessed December 2025. [3] Steiner TJ, et al; Lifting The Burden: the Global Campaign against Headache. Migraine remains second among the world’s causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020 Dec 2;21(1):137 [4] Coppola G, Brown JD, Mercadante AR, Drakeley S, Sternbach N, Jenkins A, Blakeman KH, Gendolla A. The epidemiology and unmet need of migraine in five european countries: results from the national health and wellness survey. BMC Public Health. 2025 Jan 21;25(1):254. doi: 10.1186/s12889-024-21244-8. [5] WifOR. Calculating the Socioeconomic Burden of Migraine: The Case of 6 European Countries. Available at: [https://www.wifor.com/en/download/the-socioeconomic-burden-of-migraine-the-case-of-6-eu­ropean-countries/?wpdmdl=358249&refresh=687823f915e751752703993]. Accessed June 2025. [6] Seddik AH, Schiener C, Ostwald DA, Schramm S, Huels J, Katsarava Z. Social Impact of Prophylactic Migraine Treatments in Germany: A State-Transition and Open Cohort Approach. Value Health. 2021 Oct;24(10):1446-1453. doi: 10.1016/j.jval.2021.04.1281 [7] Moisset X, Demarquay G, et al., Migraine treatment: Position paper of the French Headache Society. Rev Neurol (Paris). 2024 Dec;180(10):1087-1099. doi: 10.1016/j.neurol.2024.09.008. [8] The Economist, https://www.economist.com/china/2025/11/23/chinese-pharma-is-on-the-cusp-of-going-global, Last accessed December 2025. [9] Crescioli S, Reichert JM. Innovative antibody therapeutic development in China compared with the USA and Europe. Nat Rev Drug Discov. Published online November 7, 2025. [10] Manzano A., Svedman C., Hofmarcher T., Wilking N.. Comparator Report on Cancer in Europe 2025 – Disease Burden, Costs and Access to Medicines and Molecular Diagnostics. EFPIA, 2025. [IHE REPORT 2025:2, page 20] [11] Armstrong GB, Graham H, Cheung A, Montaseri H, Burley GA, Karagiannis SN, Rattray Z. Antibody-drug conjugates as multimodal therapies against hard-to-treat cancers. Adv Drug Deliv Rev. 2025 Sep;224:115648. doi: 10.1016/j.addr.2025.115648. Epub 2025 Jul 11. PMID: 40653109.. [12] Narayana, R.V.L., Gupta, R. Exploring the therapeutic use and outcome of antibody-drug conjugates in ovarian cancer treatment. Oncogene 44, 2343–2356 (2025). https://doi.org/10.1038/s41388-025-03448-3 [13] Coleman, N., Yap, T.A., Heymach, J.V. et al. Antibody-drug conjugates in lung cancer: dawn of a new era?. npj Precis. Onc. 7, 5 (2023). https://doi.org/10.1038/s41698-022-00338-9 [14] Wang Y, Lu K, Xu Y, Xu S, Chu H, Fang X. Antibody-drug conjugates as immuno-oncology agents in colorectal cancer: targets, payloads, and therapeutic synergies. Front Immunol. 2025 Nov 3;16:1678907. doi: 10.3389/fimmu.2025.1678907. PMID: 41256852; PMCID: PMC12620403. [15] EFPIA, Improving EU Clinical Trials: Proposals to Overcome Current Challenges and Strengthen the Ecosystem, efpias-list-of-proposals-clinical-trials-15-apr-2025.pdf, Last accessed December 2025. [16] The EU General Pharmaceutical Legislation & Clawbacks, © Vital Transformation BVBA, 2024.

Rick Pazdur, the FDA’s top drug regulator, told staff Tuesday he submitted his resignation to the agency, an abrupt departure weeks after he was convinced by Commissioner Marty Makary to take the post to help bring stability to an agency reeling from months of upheaval, according to four people familiar with the decision granted anonymity to discuss the move. The decision — which comes days after top vaccine regulator Vinay Prasad said the agency would ratchet up regulatory requirements for new vaccines — is almost certain to raise new questions about Makary’s leadership of the FDA. Pazdur in recent weeks clashed with Makary over the Commissioner’s National Priority Voucher program, according to media reports. That program — which aims to speed final review of drugs that address health priorities, pose a transformative innovative impact, address an unmet medical need, help onshoring efforts or increase affordability — was also criticized by Pazdur’s predecessor, George Tidmarsh. FDA experts have worried the involvement of political appointees in the process of choosing which firms receive a voucher could raise questions about the program’s integrity. STAT first reported the news of Pazdur’s decision to retire. It is unclear if the decision is final — one person familiar with the decision said the longtime cancer drug regulator has 30 days to change his decision. “We respect Dr. Pazdur’s decision to retire and honor his 26 years of distinguished service at the FDA,” an FDA spokesperson said in a statement. “As the founding director of the Oncology Center of Excellence, he leaves a legacy of cross-center regulatory innovation that strengthened the agency and advanced care for countless patients. His leadership, vision, and dedication will continue to shape the FDA for years to come.” The White House and Pazdur did not immediately respond to requests for comment. Pazdur, a 26-year agency veteran, initially rebuffed efforts by Makary to convince him to assume leadership of the FDA’s Center for Drug Evaluation and Research — but ultimately agreed to take the job after being assured he would be given autonomy in the role free from political influence and the ability to rehire staff.

RINGASKIDDY, Ireland — When Pfizer started manufacturing its anti-impotence drug Viagra in southwestern Ireland, locals experienced a spike in sexual arousal, five-legged rabbits proliferated, and visitors took U-turns back to their spouses after fumes from its local plant drifted in through their car windows.   That’s according to local legend, at least.  These stories “transited through the local pub,” said Pat Hennessy, a long-term resident of Shanbally, just up the road from the coastal village of Ringaskiddy. “There was a girl there and she said: ‘One whiff and they’re stiff.’”   The impact of Big Pharma on the area, however, goes far beyond amusing anecdotes: Its arrival in the 1970s turned a sleepy fishing village into an industrial powerhouse and turbocharged economic growth in County Cork. But today, the industry — and the region that depends on it — are in the eye of U.S. President Donald Trump’s tariff storm.  As he drives to slash the massive U.S. trade deficit, Trump says he is determined to reshore the production of weight-loss drugs, cancer treatments and other pharmaceuticals. He has threatened to eventually slam tariffs as high as 250 percent on the sector.  Ireland, Trump says, “took our pharmaceutical companies away” with its tax policies: Of the $213 billion of medicines the U.S. imports, the largest share comes from Ireland, a global leader in the production of expensive brand-name medicines. Dublin’s liberal tax regime has exerted an irresistible pull on U.S. Big Pharma for decades.  Locals find only limited solace in a deal struck in July between the European Union and the White House which — at least on paper — caps U.S. tariffs on pharmaceutical imports from the EU at 15 percent and exempts generic medicines. Ireland, as one of the EU’s most open economies, is particularly vulnerable to the tariffs, and uncertainty persists over Trump’s next moves and the damage they could inflict.  “It’s still like an axe hanging over us,” said David Collins, the fifth-generation owner of a family-run store in Carrigaline, a commuter town 20 minutes by bike from Ringaskiddy. “It’s a constant threat.”  The area is home to seven of the 10 largest pharma companies worldwide. More than 11,000 people in County Cork work in the industry — with tens of thousands more in ancillary jobs. Ringaskiddy alone hosts Pfizer and Johnson & Johnson, Sterling Pharma Solutions producing for Novartis, as well as smaller firms such as Recordati, BioMarin and Hovione. In addition to Viagra’s active ingredient, critical components of cardiology, immunology and oncology medications are made here.   PITCH AND PUTT  When Pfizer arrived in 1969, its workers spent their lunch breaks building a course to play pitch and putt — a scaled-down version of golf — for the local community, recalled Michael Goably, a pensioner, while enjoying his morning coffee at the clubhouse of Raffeen Creek Golf Club, nestled on the lush shores of Cork harbour.  As the name suggests, a nine-hole golf course, also built on land owned by Pfizer, now complements the pitch and putt. It’s just one example of how the area has benefited from big pharma: Ask the locals, and they’ll tell you the industry’s contribution far outweighs the side effects, such as commuter traffic and environmental pollution.  “I couldn’t say a bad word,” said Ray Keohane, another golfer taking a break on a bench between rounds.  The town of Carrigaline, once an agricultural village, now counts 20,000 residents, as well as a hotel, several supermarkets and a lively shopping street.  “When I was a child growing up in Carrigaline, there was one main industry, and it was called Carrigaline Pottery … there wasn’t a family in the area of Carrigaline that didn’t at least have one person working in the pottery,” said Collins, the supermarket owner.  “Roll on 50 years later, that’s been replaced by the pharmaceutical industries.”  CELTIC TIGER  The arrival of multinational corporations softened the impact of the closure of manufacturing sites by carmaker Ford and Dunlop, a tyre company, in the 1980s. “Ireland as a country wasn’t doing well, but Cork was a particularly black spot then,” said John O’Brien, a lecturer in finance at University College Cork. “The combination of pharmaceuticals and IT … together really have brought up the city,” he added, referring to Ireland’s second-largest city Cork, which hosts the EU headquarters of tech giant Apple.   Nationally, the success in the pharma sector helped drive economic growth in Ireland’s “Celtic Tiger” era from the 1990s to the late 2000s. That’s thanks to large-scale foreign investment — especially from the U.S. — low corporate taxes, a skilled English-speaking workforce and EU membership.  According to Louis Brennan, an emeritus professor at Trinity College Dublin, pharma’s contribution was threefold: It created high-value and high-paying jobs, led to the development of an ecosystem of suppliers and subcontractors, and generated government revenues.   Cork has also established itself as a hub for higher education in pharma-related fields.   TARIFF GAMES  Since Trump’s return to the White House, that engine of the Irish economy finds itself under (verbal) attack, exposing just how much Irish success hinges on the country’s capacity to remain the go-to location for U.S. firms, which beyond welcoming tax benefits have also long shifted their profits and patents there.  “We want pharmaceuticals made in our country,” Trump told CNBC in August.  As part of his vow to slash drug prices and bring manufacturing back to the U.S., Trump in April opened a so-called Section 232 investigation into the pharmaceutical sector to probe the impact of imports on national security and impose tariffs if needed.   Analysts estimate that Trump is unlikely to impose a tariff as high as the threatened 200 or 250 percent. However, a first “lower tariff” — no higher than 15 percent, provided Trump does indeed stick to the terms of the EU-U.S. agreement — could yet be followed by a heavily disruptive tariff of around 50 percent after a year or two. The message isn’t lost on big pharma: Giants such as Eli Lilly and Johnson & Johnson have this year announced new investments in the U.S. Yet experts warn Trump’s tariff policy risks driving up drug prices and leading to shortages, rather than spurring large-scale relocation.  While the 15 percent tariff cap foreseen by the EU-U.S. deal offers the industry a reprieve, companies need to make tricky calculations, warned Dan O’Brien, chief economist at the Institute of International and European Affairs, an Irish think tank.  “For those products that are uniquely made in Ireland there is at least some element of a buffer: It’ll take a few years for production to move out of Ireland, in a worst-case scenario,” he said. For products also made elsewhere, it will be easier to shift production and “could happen more quickly,” he added.  RISKY BUSINESS   For now, those scenarios remain hypothetical — but the unpredictability is already leaving its mark.   As companies rushed to export their goods, Irish pharma exports to the U.S. surged by nearly 50 percent in the first five months of this year. “Geopolitical concerns” now rank among the top three threats to business in the Cork Chamber of Commerce’s last survey of its members.  Companies are mostly keeping quiet. Pfizer and Johnson & Johnson declined to comment for this story, whereas Sterling Pharma Solutions, BioMarin, Recordati and Hovione did not respond to requests for comment. Novartis, which is supplied by Sterling Pharma Solutions, warned that “the introduction of tariffs risks creating additional barriers that could further delay access to life-saving treatments.”  Giants such as Eli Lilly and Johnson & Johnson have this year announced new investments in the U.S. | Cristina Arias/Getty Images Reacting to the deal between the EU-U.S. deal, the Irish Pharmaceutical Healthcare Association warned that “tariffs on medicines would be a substantial new cost where there was none before and a drag on investment, jobs and innovation.”  A worker at a pharma plant in the area, granted anonymity to protect their job security, told POLITICO output had slowed in the last couple of months as the company waited to regain planning certainty. Similarly, Dan Boyle, a Green Party councillor for Cork and the city’s former mayor, said companies told him that “our hope was that we would have announced future investment for 2030, and that’s being sat on, until we know what the situation is going to be.”  UNDER PRESSURE  Local, national and European politicians are acutely aware of just how much is at stake.  Séamus McGrath, a Dáil deputy for the Cork South-Central constituency, called for a “continuous process of renegotiation and engagement” with Washington.   “We need to renew our pitch and renew our attraction as a country for foreign direct investment,” said McGrath, sitting in the lobby of the Carrigaline Court Hotel, the town’s only hotel. “You cannot sit back.”   The politician with the co-governing centrist Fianna Fáil party entertains strong ties with Brussels, not least thanks to his brother, EU Justice Commissioner Michael McGrath.  In the EU capital, lawmakers from the region are urging the EU to boost the bloc’s competitiveness. Cynthia Ní Mhurchú, of the liberal Renew Europe group, called for cutting “excessive red tape” for businesses. And Seán Kelly, an MEP with the centre-right European People’s Party, welcomed the European Commission’s plans to secure access to new markets through trade deals.  After all, for locals back on the Irish coast, power politics determine no less than their personal future.  “They say they [the big companies] will go away,” said Amy Lyons, a bartender at Ringaskiddy’s only pub, The Ferry Boat Inn.    “I’m doing a biopharma course in college. So, imagine I get my degree, and they are gone,” she added as she drew pints for the regulars, who were discussing a new road being built to ease road congestion — caused by commuter traffic to the pharma plants.  Graphics by Hanne Cokelaere.